- The Washington Times - Friday, September 9, 2005

Often I find merit in the quip we are, indeed, a two-party system — the Stupid One (Republican) and the Evil One (Democratic). Recently, however, the overwhelmingly Democratic California congressional delegation seems to be poaching on the Republicans’ turf.

The issue is a somewhat arcane one: using human volunteers to test certain pesticides before introducing them to the market. Government regulators and public health experts around the globe, along with myriad scientific bodies, support qualified use of human clinical studies in the approval process for pesticides. However, several scientifically challenged members of California’s congressional delegation have intervened to prohibit the Environmental Protection Agency from considering these tests in its evaluation — even if the results have already been obtained.

Sen. Barbara Boxer, California Democrat, who is widely believed to have the IQ of a California artichoke, and California Democratic Reps. Henry Waxman and Hilda Solis crafted an amendment to the EPA’s appropriations bill that seeks a one-year moratorium on EPA use of data from human studies.

During Senate consideration of the bill, Sen. Conrad Burns, Montana Republican, who represents common-sense farmers and ranchers, sponsored a conflicting amendment to mandate EPA review of all human studies under consideration to be certain they were conducted safely and ethically.

During the conference committee on the appropriations bill, a compromise was reached that would prohibit EPA from proceeding with human studies until it produces a final regulation on the issue. As EPA began circulating its draft rule through bureaucratic channels, enter the intra-EPA guerrilla group known as PEER — Professional Employees for Environmental Responsibility — which leaked the proposal to the media. PEER claimed the draft rule ignored congressional intent and should be trashed.

That provided an entree for Mrs. Boxer to complain in a letter to EPA Administrator Steve Johnson that EPA is advancing “an arrogant response… to congressional direction.” Mrs. Boxer and her colleagues try to frame this issue as an affront to ordinary, vulnerable people, alleging pregnant women and children could be exploited by profit-minded industry.

This is a grotesque mischaracterization: Only healthy, nonpregnant adult volunteers would ever be tested.

The legislators chose to ignore the findings of the most prestigious U.S. scientific body, the National Academy of Sciences, which after an exhaustive study said in a February 2004 report it is in the public interest to maintain the availability of products that both ensure an abundant, affordable high-quality food supply and protect public health by controlling disease-carrying pests, such as mosquitoes, ticks and roaches. The NAS also observed human studies are only done when existing data cannot answer a scientific question.

Democratic politicians seem to habitually take the wrong side of pesticide issues. Under Senate rules, any senator can put a “hold” on a presidential nominee who requires confirmation, with 60 votes required to overturn it, making it similar to a filibuster. Several months ago, Sens. Boxer and Bill Nelson, Florida Democrat, placed holds on the nomination of Mr. Johnson, then acting EPA administrator, demanding he cancel a study of the effects of pesticides on infants and babies if he wanted to be confirmed. A day later, Mr. Johnson complied. A spokesman for the EPA admitted Mr. Johnson canceled the study because of the holds on his confirmation.

Some Democratic critics have misrepresented that study as requiring the deliberate spraying of infants with pesticides, with their parents receiving money and other remuneration from the government. But that is another lie.

The truth is the study would have analyzed the results of exposure to routine household applications of pesticides, with the subjects’ parents receiving modest compensation for permitting examinations and measurements.

The study’s worthy goal was to ascertain if routine applications can result in toxic levels of pesticides under normal domestic usage. It would both have benefited the subjects and provided important information to government and industry scientists.

The senators’ ethically dubious actions, and Mr. Johnson’s cowardly capitulation, derailed a useful public health project.

To illustrate the absurdity of all this, suppose senators on both sides of the issue made conflicting demands of Mr. Johnson as conditions of confirmation — some demanding the study stop, others asking it be expanded. How do we make a decision on a critical public health issue — flip a coin?

Provided safeguards are in place and sound scientific principles used, human testing is ethical and appropriate, and may, indeed, be lifesaving.

But the Boxers and Waxmans — ignoring directives by Congress, EPA and international scientific protocols such as the Common Rule, Declaration of Helsinki and Good Clinical Practice — think they know better. Or perhaps they’re just demagoguing, seemingly one of their proficiencies.

The machinations of the California congressional kooks (including honorary member Mr. Nelson) are an affront to victims of West Nile virus, Lyme disease, or roach-allergy asthma and anyone prone to infected insect bites. Their misery might have been prevented, had demagoguing politicians not prevented testing of new and more effective products.

Henry I. Miller, a physician and fellow at the Hoover Institution, headed the Food and Drug Administration’s Office of Biotechnology from 1989-1993. His latest book, “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution,” was picked by Barron’s as one of the 25 Best Books of 2004.

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